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Breakfast Intake and Satiety Hormones

Does Higher Protein Quality Breakfast Reduce Energy Intake When Following a Weight Loss Diet Plan?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02497859
Enrollment
20
Registered
2015-07-15
Start date
2015-09-30
Completion date
2016-05-31
Last updated
2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Weight Reduction, Weight Loss Diet, Satiety Response, Insulin, Glucagon-Like Peptide 1, PYY (3-36) peptide, Ghrelin, Glucose, Eggs, Protein, Energy Intake, Breakfast

Brief summary

The experiments in this study will assess if while following a reduced energy diet, eating a breakfast with higher protein quality will enhance weight loss compared to another breakfast with lower protein quality, but matched for energy density and macronutrient composition.

Detailed description

There will be 2 experiments in this pilot study. Both will be randomized crossover study designs with subjects beginning on either an egg breakfast of higher protein quality or cereal breakfast of lower protein quality, and reversing to receive the breakfast not previously ingested. The subjects will consume breakfasts under supervision at our clinic on all days of the study, except for weekends. Subjects will be advised to continue eating their breakfast at home on weekends. All subjects will receive weight loss counseling and follow a weight loss diet for 2 weeks. Experiment 1 will test the hypothesis that when on a reduced calorie diet, intake of an egg breakfast compared to cereal breakfast increases satiety, reduces lunch time energy consumption and reduces dinner time energy consumption in clinical and free living condition. Insulin, glucagon-like peptide-1, peptide YY 3-36, ghrelin, plasma glucose, baseline and post intervention anthropomorphic measurements, and hunger questionnaires completed during the consumption of both breakfasts and subsequent meals will be compared. Experiment 2 will compare the effects of the two breakfasts on intake of foods considered tempting or highly palatable, and assessment of energy intake pre/post test lunch followed by offering brownies. It is hypothesized that consumption of an egg breakfast compared to cereal breakfast, will help in reducing intake of foods considered tempting.

Interventions

The EB will receive a breakfast of higher quality protein, but similar in macronutrient and energy density than the active comparator. The EB will have the following energy density, macronutrient composition, and protein score: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.5%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.

The CB will receive a breakfast of lower quality protein, but similar in macronutrient and energy density than the experimental treatment. The CB will have the following energy density, macronutrient composition, and protein score: weight 293 g, energy 398 kcal, energy density 1.3 kcal/g, carbohydrate 44.8%, fat 35.4%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 42, leucine 0.48 g, glycemic load 30.8, fiber 4.4 g.

Weight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics including portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, will be discussed. Self-monitoring, motivational interviewing, goal setting, and problem solving will be the behavioral strategies used during counseling.

Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.

Sponsors

American Egg Board
CollaboratorOTHER
Texas Tech University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

* Calculated BMI of 25.0-39.9 kg/m2 * Sedentary (\< 3 hours/week of moderate intensity physical activity) * Otherwise healthy

Exclusion criteria

* ≥5% body weight loss or gain in the three months preceding the study * Post-menopausal (has not had period for 12 months) * Plans to begin an exercise program or change current exercise routines between initiation of study and final study * Anyone following a medical diet prescription * Anyone with a chronic disease including type II diabetes, hypothyroidism, hypoparathyroidism, cardiovascular disease, cancer of any type * Health conditions and chronic illness that contraindicate behavioral weight loss treatment using a low calorie diet * Anyone who is currently pregnant, or lactating * Medications that may influence or inhibit appetite, sensory functioning, or hormone signaling * Plans to begin taking any supplements that may influence weight loss * Report of medical condition or surgical intervention that affects swallowing or chewing ability * Anyone with a pacemaker or other internal medical device * Any practicing vegans or vegetarians * Any practicing gluten-free diet * Allergy, aversion, or dislike to any of the foods offered for meals

Design outcomes

Primary

MeasureTime frameDescription
Energy intake (kcal) during ad libitum dinnerTest day 7 (30 minutes for buffet).This is for experiment 1.
Change in subjective hunger questionnaire (Visual Analog Scale)Change in scores (arbitrary units AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.
Change in serum satiety and hunger hormonesChange (AU) from 30 minutes prior to breakfast consumption to 240 minutes post consumption.Concentrations of ghrelin, GLP1, PYY 3-36, insulin, and serum glucose will be determined. This is only for experiment 1.
Energy intake (kcal) during ad libitum lunchTest day 7 (30 minutes for buffet).This is for experiment 1.

Secondary

MeasureTime frame
Change in body weight in kilogramsChange in kilograms from baseline to test day 7.
Change in waist and hip circumference in centimetersChange in centimeters from baseline to test day 7.
Change in blood pressure (mm Hg)Change in mm Hg from baseline to test day 7.
Change in fat mass and lean body mass percentageChange in percentage from test day 0 to test day 14.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026